National Center for Immunization & Respiratory Diseases

Centers for Disease Control and Prevention 

Nirsevimab: Implementation 

Considerations

Georgina Peacock, MD, MPH, FAAP

Director, Immunization Services Division

National Center for Immunization and Respiratory Diseases

Centers for Disease Control and Prevention (CDC)
Implementation Considerations

• Definition of Vaccine

• Cost

• Storage and Handling

• Hospital Dosing

• Outpatient Dosing

• Coding and Immunization Information Systems

• Timing of Vaccination

• 2

nd Year Vaccinations

• Vaccine Administration

• Safety Reporting

• Vaccine Confidence and Demand
• No statutory definition of vaccine in the statute for the Vaccines for Children (VFC) program 

(section 1928 of the Social Security Act)

• No statutory definition of vaccine in the Affordable Care Act (section 2713 of PHS Act), or its 

implementing regulations, which has a provision that mandates coverage of vaccine 

recommendations included on CDC’s immunization schedules

• CDC has determined that nirsevimab is eligible for inclusion in the childhood immunization 

schedule and Vaccines for Children program

Definition of “Vaccine”

Program For Distribution Of Pediatric Vaccines

Coverage of Certain Preventive Services Under the Affordable Care Act
• Cost of nirsevimab estimated at $495 per dose in the private sector

• If recommended by ACIP, nirsevimab will be covered by insurance and included in 

the VFC program

o Importance of ensuring equitable access to nirsevimab

• However, nirsevimab cost will still be a potential implementation barrier particularly 

for ambulatory practices

o If nirsevimab included in VFC, practices must carry both VFC and private stock, 

which may be challenging for some practices

Cost
• Similar to other routine vaccines for children

• Administered as intramuscular injection using single-dose pre-filled syringe

o Can be administered simultaneously with other childhood vaccines

• Dosed by weight/age

o 50 mg if <5 kg

o 100 mg if ≥5 kg

o 200 mg (2x100 mg) for high-risk children entering 2nd RSV season

• Stored in refrigerator at 2-8

◦ C

• May be kept at room temperature (20-25◦ C) for up to 8 hours

Nirsevimab Storage, Handling, and Administration

Source: California Department of Public Health
▪ Jurisdictions may have different scope of practice statutes for who can administer 

injectable therapeutics vs. vaccines

▪ Scan of state laws indicates that most states allow medical assistants (who frequently 

administer vaccines) to also deliver injection drugs

o However, organizations may have varied practices

Scope of Practice Issues

American Association of Medical Assistants
▪ Approximately 10% of birthing hospitals participate in the VFC program

▪ Bundled payment model for newborn care

o Hepatitis B vaccine more feasible to cover at ~$13–16/dose

o Will nirsevimab be included in bundled payments?

▪ Critical to ensure documentation of in-hospital nirsevimab administration in records 

sent to primary care provider

o Potential challenges entering nirsevimab in the immunization information 

system (IIS)

o Comprehensive maternal-neonatal records will become even more critical if 

maternal RSV vaccine is licensed and recommended

Hospital Administration

CDC Vaccine Price List
• Communication from birthing hospital

• Communication about maternal RSV vaccine

• Initial investment by pediatricians – unsure on price and demand for nirsevimab nor 

demand for new product

• Historical lag in insurance payment for new products

Outpatient Administration
• CPT coding and AMA decision around CPT codes — classified as a drug/therapeutic

• Administration codes do not include a counseling component

• Not eligible for stand-alone counseling

• Potential challenges with recording doses in Immunization Information Systems

Coding
Preparing Systems for Administering a Newly Authorized Vaccine

Across the U.S.

Timeline represents standards for vaccines. Incorporating a MAB 

into vaccine systems has the potential to expand timeline due to 

increased complexity.

Code set subscription services activate. CDSi resources 

are published. Provider & payer systems use these for 

system development & deployment.

Data publication partners

(FDA, CDC, formulary vendors, & AMA)

Prepare & publish vaccine & drug code 

set files for systems development

10-12+

Weeks

9

Weeks

BLA

Approved

2 

Weeks

3 

Weeks

4 

Weeks

5 

Weeks

6 

Weeks

1 

Week

7

Weeks

Provider & payer systems ready to record 

& report vaccine administration

IIS systems prepare for 

new vaccine codes

6-12+ weeks post authorization

Vaccine ready for VTrckS

ordering & distribution

~2 weeks post authorization

8 

Weeks

1-4+ weeks post authorization

1-4+ weeks post authorization 1-4+ weeks post authorization
• Nirsevimab coded as a therapeutic instead of vaccine could create challenges with:

o Internal provider ordering

o Provision of a vaccine record

o Interoperability/data exchange with electronic health record (EHR) and IIS

• Forecasting (Clinical Decision-Support [CDS] for immunization)

o Dosage by weight: CDS does not have access to patient weight

o 2

nd season recommendations

o Future considerations: CDS systems unable to take into account maternal 

vaccination history for forecasting for infant nirsevimab immunization

IIS and Vaccine Forecasting Considerations
• Timing of vaccination based on RSV season

o Tropical climates may have different/unpredictable seasonality when compared 

to most of continental U.S.

• Variability in different localities

o For example, seasonality in AK less predictable and longer duration

• Second year dosing

o High risk populations

o Clarifying palivizumab recommendations in the setting of nirsevimab availability

Special Considerations Add Complexity
• Reporting of suspected adverse events (AEs) more complicated for nirsevimab than 

other immunizations:

o If nirsevimab is administered alone, suspected AEs are reported to MedWatch

o If nirsevimab is administered simultaneously with any vaccine, suspected AEs are 

reported to the Vaccine Adverse Event Reporting System (VAERS); additional 

reporting to Medwatch not needed

Reporting of Adverse Events by Patients and Providers
• Will physicians and public accept a new vaccine

• Occurring at the same time as commercialization of COVID-19 vaccine 

and seasonal influenza administration

• Vaccine hesitancy and anticipated need for counseling around all 

vaccines and products

• Efforts to weaken school immunization requirements and expand 

vaccine exemptions at the state level

Vaccine Confidence/Demand
• Considerations for implementation

• Risks during this season’s roll out

o Timing of availability of doses

o Provider hesitancy 

o Uptake 

• Complexity of recommendations

o Hospital vs. Outpatient

o Seasonality / Timing

o Lessons learned with Hepatitis A and B

• Unintended consequences

Conclusion and Discussion
For more information, contact CDC

1-800-CDC-INFO (232-4636)

TTY: 1-888-232-6348 www.cdc.gov

The findings and conclusions in this report are those of the authors and do not necessarily represent the 

official position of the Centers for Disease Control and Prevention.

Thank You!